According to sources, on August 27, us time, voopoo Wupu, a brand of Gilbert technology, formally submitted a pre marketing tobacco product application (PMTA) to the US FDA.
The full name of PMTA is premarket tobacco product application. Products already sold in the United States must submit a PMTA application within the specified time, otherwise they will not be sold in the U.S. market.
It took 20 months from preparation to application
Voopoo said that since the FDA announced the first version of the relevant provisions of PMTA in 2017, a special team has been set up to conduct in-depth project research and analysis. The team members include toxicology experts, clinical medicine experts, PMTA project experts, product analysts, R & D experts, legal consultants, marketing personnel, etc.
The whole application process cost 100 million yuan. It took 20 months from preparation to application, and PMTA testing requirements such as product composition analysis, manufacturing research, non clinical and clinical human body research were completed.
According to the data and conclusions drawn by the cooperative laboratory, the performance indicators of several voopoo brand products under Gilead's brand are excellent in composition analysis, toxicology research, design and manufacturing, and chemical test, which also makes voopoo team confident in PMTA project audit.
In addition, voopoo also invested millions of dollars to upgrade the factory to achieve a higher standard of manufacturing environment and quality management system. At present, it has formed a modern manufacturing center integrating 100000 level dust-free and clean workshops, MES intelligent supply chain management system, automatic production equipment and traceability quality control of the whole process, fully ensuring the standardized and intelligent management of design and development, product raw materials, production manufacturing, product testing, quality control and other processes, and providing world-class quality experience.
This is a protracted war,
It's a battle of life and death
As the strict product listing standard of the global e-cigarette industry, the application process of PMTA is very complex, and the audit is extremely rigorous and scientific. Relevant institutions speculate that it will take about two years for the application of PMTA to be approved.
This not only requires the product to have excellent quality performance, but also needs the enterprise's own strong capital reserve and long-term preparation. It is precisely because of the high cost and long preparation time that the entry threshold of e-cigarette brands in the U.S. market has been greatly improved.
Therefore, this is a protracted war on capital and time, and also a life and death war on quality and safety.
Only the electronic atomization brand with real financial strength and technical strength, grasping product quality and strictly preventing safety problems can pass the test of PMTA.
The application of PMTA also shows voopoo's fearless industry challenges and the spirit of striving forward, adhering to the original intention of providing better and safer products for global users.
A new starting point
It is understood that from the beginning of its establishment, voopoo has always insisted on putting product safety in the first place and firmly undertakes the corporate responsibility for the industry, users and society.
Through PMTA, voopoo is of great significance, not only the quality and safety of the product itself has been recognized by the world's most stringent food and drug administration, but also a strong demonstration of the enterprise's all-round strength.
In addition, FDA requires that all marketing products on the market must prevent young people from contacting and exposing them. For minors, this will greatly protect their physical and mental health and fulfill the responsibility and responsibility of guarding the growth of minors in the whole industry.
PMTA application can be seen as an obstacle to the atomization industry and a new starting point.
Everest, founder and CEO of Geer technology and voopoo brand, said that next, it will continue to uphold the spirit of innovation and self breakthrough, continue to deepen product innovation and standard control, ensure the health and safety of global consumer users, lead the market with product and technology innovation under PMTA standard, promote the orderly and good development of the industry, and bring better life experience for global users.